MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS II REAMER, 5MM - HUDSON CONNECT; MANUAL INSTR, GENERAL SURGICAL

Model Number	UNIVERS II REAMER, 5MM - HUDSON CONNECT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12th november 2024, it was reported by a sales representative via email that an ar-9202-25h arthrex univers ii was stuck/lodged on the t handle.This was detected during use in an rtsr procedure on (b)(6) 2024.When surgeon was performing rtsr, arthroplasty case, the universe ii reamer, 5 mm hudson connect was stuck/lodged on the t handle.It was not able to disconnect during surgery and only 1 t handle could be used for the remainder of the surgery, which caused inconvenience for the surgeon.Procedure was successfully completed with no patient harm by using 1 t handle for the remainder of the reamers.After the surgery, it was identified that the issue was with the reamer and not with the t handle.Scrub nurse and surgeon tried to disconnect the reamer from the t handle but were unsuccessful during surgery.When surgery was completed, it was disconnected by the csu staff.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: UNIVERS II REAMER, 5MM - HUDSON CONNECT
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20733660
• Report Number: 1220246-2024-08570
• Device Sequence Number: 12999157
• Product Code: MDM
• UDI-Device Identifier: 00888867058446
• UDI-Public: 00888867058446
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UNIVERS II REAMER, 5MM - HUDSON CONNECT
• Device Catalogue Number: AR-9202-25H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown